FENTANEX

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Wirkstoff:

FENTANYL CITRATE

Verfügbar ab:

KIMIA FARMA Tbk. - Indonesia

INN (Internationale Bezeichnung):

FENTANYL CITRATE

Dosierung:

0.0785 MG

Darreichungsform:

INJEKSI

Einheiten im Paket:

DUS, 5 AMPUL @ 2 ML

Hergestellt von:

DEMO S.A. PHARMACEUTICAL INDUSTRY - Greece

Berechtigungsdatum:

2021-10-25

Fachinformation

Page 1 of 10
FENTANEX
_fentanyl_
DOSAGE FORMS AND STRENGTHS
Fentanyl is a sterile, preservative-free, isotonic aqueous solution
for intravenous use.
Each mL contains 50 mcg fentanyl (_as fentanyl citrate_).
For excipients, _see List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
Fentanyl is indicated:
For use as an opioid analgesic supplement in general or regional
anaesthesia.
For administration with a neuroleptic as an anaesthetic premedication,
for the induction of anaesthesia, and
as an adjunct in the maintenance of general and regional anaesthesia.
For use as an anaesthetic agent with oxygen in selected high-risk
patients undergoing major surgery.
DOSAGE AND ADMINISTRATION
DOSAGE
The dosage of Fentanyl should be individualized according to age, body
weight, physical status, underlying
pathological condition, use of other drugs, and type of surgery and
anaesthesia.
The initial dose should be reduced in the elderly and in debilitated
patients. The effect of the initial dose
should be taken into account in determining supplemental doses.
To avoid bradycardia, it is recommended to administer a small
intravenous dose of an anti-cholinergic just
before induction._ _
_Use as an analgesic supplement to general anaesthesia _
Low dose: 2 µg/kg
Fentanyl in small doses is most useful for minor, surgery.
Moderate dose: 2-20 µg/kg
Where surgery becomes more complicated, a larger dose will be
required. The duration of activity is
dependent on dosage.
High dose: 20-50 µg/kg
During major surgical procedures, in which surgery is longer, and
during which the stress response would be
detrimental to the well-being of the patient, doses of 20-50 µg/kg of
Fentanyl with nitrous oxide/oxygen have
been shown to have an attenuating effect. When doses in this range
have been used during surgery, post-
operative ventilation and observation are essential in view of the
possibility of extended post-operative
respiratory depression.
Supplemental doses of 25-250 µg (0.5-5 mL) should be tailored to the
needs of the patient and to the